Clinical data
services

Ensuring you gain the best from your clinical data

Clinical data services

Our vast experience in clinical data services helps us understand the nuances of data management, Biostatistics & Programming, Data Standardization, Medical Writing, and Submissions. Navitas Life Sciences is a CDISC registered solutions provider, delivering high quality clinical data while maintaining stringent regulatory compliance standards. With Navitas Life Sciences as your partner, you benefit from our extensive domain knowledge, adeptness with technology, and consulting expertise to bring data driven clinical trials to a successful completion.
Our ability to provide end-to-end services is possible as we have suitable support from experts in the industry and academia. These carefully appointed partnerships have helped us deliver high quality data seamlessly.

Perks of partnering with
Navitas Life Sciences

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Domain expertise

We have deep domain expertise through decades of working with leading pharmaceutical and biotech companies. Our highly qualified teams of data managers, and programmers include numerous SMEs with multiple years of experience in leading data management platforms and SAS Programming.

High on Quality

As a registered CDISC solutions provider, we understand the need to build quality by design, right from start-up to closure. With an exemplary track record, Navitas is the ideal partner for all your clinical data needs.
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State of the art Infrastructure

Our services are backed by state-of-the-art technology, industry affiliations, years of experience, and qualified domain experts, who deliver cost-effective data management services to address increasingly complex clinical data sets while conforming to the regulatory requirements of CDISC submissions.

Our unmatched experience

The data from clinical trials is extensive and it needs to be collected appropriately, streamlined, analyzed and presented in formats that are in accordance with regulatory compliance standards. With our expertise, we can deliver you greater efficiencies in terms of time, effort and cost, while ensuring the highest quality outcomes for your clinical trial. Our expert medical writing team includes physicians who have an in-depth knowledge about various therapeutic areas and will support your medical writing services from phase I to phase III and beyond to post authorization studies.

Right experience

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Pages of
data entry
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unique CRFs
designed
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edit
checks

Immense Volume
of data

Clinical data management

Extensive reporting

Biostatistics and statistical programming

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reports
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studies
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ADaM datasets

Wide range of reports

Clinical data standardization

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SDTM studies
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ADaM studies
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SDTM define.xml
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ADaM define.xml

Substantial experience

Medical writing

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studies supported
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web synopsis
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Protocols and study reports for phase trials and Non-Interventional Studies
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medical data reviews& discrepancy management

We are with you all the way

At Navitas Life Sciences, we have the right technology to support your data management needs. We deliver full clinical data services across CDM, Biostatistics, Statistical programming and Medical Writing through a flexible, scalable and global delivery model.
We understand your need for our teams to be onsite, offshore, near shore or a combination. We can cater to it depending on your short- and long-term objectives.

Right support

Multiple platforms in clinical data management

  • OneClinical,
  • InForm,
  • Rave,
  • Medrio,
  • OCRDC

Experts in clinical data standardization

Armed with 10 years of data conversion experience, it’s no wonder that we have delivered high volume of studies

Multiple submission capability in biostatistics and statistical programming

  • IA,
  • CSR,
  • DMC,
  • IB,
  • PSUR,
  • RMP,
  • ISS/ISE,
  • Pooling

Platforms in medical writing

QbD design approach with medical data review using OneClinical

Leverage our high quality, timely and efficient clinical data services for your study

Successful outcomes using our clinical data services

End-to-End clinical data services drive successful outcomes

Find out how this resulted in site improvements including CRF/ DCF Aging, with Site report reduced from ~60%-70% to ~10-15% within 3 months.

Clinical Data Services case study

Clinical data management

Clinical trials are adaptive and spread across multiple sites, making data integrity integral to the success of your trial. Efficient collecting, transferring, and managing of data during a clinical trial is critical for the smooth functioning of the drug development process.

Navitas Life Sciences ensures best in class Clinical Data Management services to enable effective study design, conduct, discrepancy management, close-out and regulatory compliance.

Select from our stellar Clinical Data Management services

  • OneClinical
  • Inform
  • Rave
  • Medico
  • OCRDC

Gain from our exceptional data integrity, collection, transfer and data management services

Be first to market with our exceptional clinical data management

Clinical Data Management case study

Flexible clinical data management services enable successful submission

Database delivery timelines shortened by 20% despite increase in the number of unique CRFs
by 300% (from 23 unique CRFs to 72 Unique CRFs)

Biostatistics & Statistical Programming

The Navitas Life Sciences biostatistics and statistical programming team consists of highly qualified and experienced statistical programmers. To understand your unique needs, our expert programmers will get in touch with your biostatisticians to give you exceptional analysis datasets and tables, listings and figures (TLF)as provided in your protocol or Statistical Analysis Plan (SAP).

Our onus has always been on delivery excellence which is possible by leveraging our domain experience in clinical trial data analytics and an in-depth knowledge of CDISC standards across multiple therapeutic areas. Navitas Life Sciences Biostatistics & Statistical Programming team will partner with you throughout the process of data acquisition, management and collation, delivering high quality content for successful regulatory submissions.

Your Partner for high quality Biostatistics and Statistical Programming

  • Creation of safety and efficacy related TLGs and CDISC datasets
  • Multiple submissions: IA, CSR, DMC, IB, PSUR, DSUR, RMP, ISS/ISE, Pooling

Benefit immensely from our biostatistics team for all your data analysis needs

As a CDISC Registered Solutions Provider, Navitas Life Sciences delivers high-quality data and ensures regulatory compliance

Biostatistics & Statistical Programming case study

Our Biostatistics and statistical programming model will help achieve success in your clinical Submission

Experienced Navitas Life Sciences’ SAS Programmers facilitated the client’s trial programmer role while enhancing the client productivity tool by including a GUI, incorporating authorized/restricted access, standardizing meta data, validating data and adding weekly reports and metrics

Clinical data standardization

Clinical trials are essential to identify the efficacy of newly developed drugs. However, pharma companies face a lot of problems like not having access to all levels of data, accuracy issues with derived analytics and an inability to deliver analytics rapidly and in an understandable manner. Our efficient process-based methodologies have been designed to create reusable source-target mappings for the generation of CDISC SDTM or ADaM datasets and submission ready documentation within a single process.

Our senior data standards consultants on our team excel at ensuring that the SDTM and/or ADaM is achieved efficiently, enabling you to adhere to regulatory compliance standards.  A vital step in our process is to ensure that a single interpretation of the SDTM is identified, documented, managed, implemented and communicated consistently.

Precise data standardization methodologies

  • Reusable source-to-target mapping specifications
  • Optimized process to specify critical tabulation domain derived Variables
  • Streamlined process to design and populate the Trial Design domains
  • Efficient data transformation techniques
  • Mapping of both ongoing and legacy data in compliance with CDISC SDTM
  • Defining Sponsor-specific data standards in accordance with CDISC
  • Shorter submission timelines
  • Improved ability to perform efficient analysis
  • Centralized metadata repository for end-to-end process efficiencies
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Data Standardization
case study

Dedicated Data Standardization support to eliminate risk of rejection

Find out how complexities caused by unique data sets and aggressive timelines were handled effectively, with on time high quality submissions

Efficient methodologies for effective data standardization

SDTM and/or ADaM developed in the most efficient and compliant manner

Medical Writing

Medical Writing is an integral part of clinical research, with our team delivering accurate, cost effective and high-quality documents to facilitate better drug development process. Our responsive medical writers will work with your team, transforming complex and diverse data into an evidence-based and precise account of your product’s clinical profile, with respect to treatment and patient safety.

The Right Partner for your Medical Writing Needs

  • QbD design approach
  • Medical Data Review using One Clinical Platform

Medical Writing
case study

On time, High quality Medical Writing service

At Navitas, we understand the complexities of a clinical trial and have vast experience and technical know-how, along with the right expertise to document your clinical trial